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With the changes in ISO13485 authorizing notified bodies to perform unannounced audits at what you have identified, or the NB believes, to be critical elements in the value chain. What a boon to NB’s they get to charge us for the cost of audits at our critical suppliers even though that supplier may not have a registered quality system. I liken this to the police showing up unannounced at your Grandmother’s house and going through every cabinet and drawer without a warrant, just because they have a “suspicion” that you might be eating Grandma’s special cookies. And to top it all off you have to pay for this intrusion. It is common knowledge that most manufacturers are not entirely vertically integrated. Few of us “do-it-all” today. Most have some contract manufacturer or supplier of critical components in their “up-front” supply chain. Many of us in the MedDev community have distribution and service providers in the “downstream” supply chain, but do we think of our as critical suppliers? Many have agreements with partners that manage the post manufacturing supply chain, taking orders, delivering products and services to customers and taking customer feedback. In the MedDev arena, these could be considered “Critical Suppliers”, as they perform functions that are integral parts of quality system regulatory requirements of the manufacturer. Distribution record keeping, Customer complaint and adverse event information gathering, Product recalls or remediations, repair services, and Customer relations are functions often passed on to our downstream business partners, although we as manufacturers retain the responsibility for regulatory compliance. Do we truly know their capabilities to perform these functions? Do they have robust systems in place? Are they keeping the necessary regulatorily required documents? Do we get all the data in a timely manner? The risk is there. What would be the audit findings if an auditor showed up unannounced at one of your downstream partners today? Do you know? have you done complete Front to Back supply chain due diligence? source: https://www.linkedin.com/groups/78665/78665-6071767682309509120 Marked as spam
 Posted by Asked on November 15, 2015 8:00 am
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Marcelo Antunes
I think you meant to to say "changes in medical devices regulations in Europe authorizing notified bodies to perform unannounced audits", not ISO 13485. ISO 13485 (not even the new version) has nothing to do with unannounced audits.
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CEO -Shuky- Liat Nadel-Isr.Reg.Holder
Following the new EU MD regulations
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Karen Boyd, ASQ CQA
The message is: Qualify, select, and maintain diligent control of your critical suppliers; you, as manufacturer, are ultimately liable - good and bad.
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Most Notified Bodies are asking the clients to list its critical subcontractors or crucial suppliers so that they can understand the best opportunity to witness product testing or witnessing critical processes during an unannounced visit, as this is the key requirement of these visits. I would recommend that if companies have identified the companies that may be visited unannounced visits, then agreements are put in place, allowing the access of the Notified Body.
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Karen Boyd, ASQ CQA
It is my understanding and experience that critical suppliers / subcontractors would or could be required for 3rd party audits as well as pertinent to product technical files, or design dossiers.
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For existing critical suppliers, since agreements would already be in place, an acknowledgement from the critical supplier that “they are aware of the unannounced NB audit recommendation and will permit the NB for such an inspection” will suffice. However for future critical suppliers, requirement to allow access to a NB for unannounced inspection should be included as part of the agreement. Probability of an unannounced inspection would be higher for a critical supplier providing completed assemblies/near finished product compared to one providing raw materials and where major processing takes place at a manufacturer’s facility.
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Michael Wienholt, RAC
See my blog on this topic for background and a recommendation: https://www.linkedin.com/pulse/critical-subcontractors-crucial-suppliers-wienholt-rac-us-eu-?trk=mp-author-card
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